A prospective randomized comparative study of the effects of intranasal and transdermal 17 beta-estradiol on postmenopausal symptoms and vaginal cytology.

CONTEXT

Investigating the adverse effects of oral hormone replacement therapy (HRT), the clinical effectiveness of alternative combinations and route of administrations.

AIM

To compare the effects of intranasal and transdermal 17 beta-estradiol combined with vaginal progesterone on vasomotor symptoms and vaginal cytology.

SETTINGS AND DESIGN

A 12-week, prospective, randomized comparative study was conducted between July 2005 and September 2006.

MATERIALS AND METHODS

Eighty postmenopausal women aged between 42-57 years, who had scores of > or =1.7 on the menopause rating scale-I (MRS-I) items "1-6", were randomly assigned to receive intranasal (300 microg/day, n =40) or transdermal (50 microg/day, n =40) 17 beta-estradiol continuously. All patients also received a vaginal progesterone gel twice weekly. Vasomotor symptoms were evaluated at weeks 0, 4, 8 and 12. Vaginal maturation index (VMI) was evaluated at weeks 0 and 12 of the study.

STATISTICAL ANALYSES

The Mann-Whitney U and the Wilcoxon tests were used. P < 0.05 was regarded as significant.

RESULTS

Thirty-two women in the intranasal and 29 women in the transdermal group completed the study. The total score of the MRS, the sum-scores of Factor 1 "HOT FLUSHES" and Factor 2 "PSYCHE" significantly decreased in both groups at week 4. Factor 3 "ATROPHY" scores significantly decreased only in the transdermal group at week 12. The VMI showed no changes within and between the two groups at the end of the study.

CONCLUSION

Intranasal and transdermal 17beta-estradiol combined with vaginal progesterone gel as a continuous HRT caused a similar decrease in vasomotor symptoms but did not have any significant effect on VMI after 12 weeks of treatment in this study population.